Quality Manager (full-time, remote)

P 95; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

Join a dynamic and fast-growing organization focused on improving healthcare through innovative medical research. As a Quality Manager, you'll develop and maintain a robust Quality Management System, ensuring compliance with GxP regulations. This role offers the opportunity to work autonomously while collaborating with a diverse team across the globe. You'll be empowered to drive continuous improvement and operational excellence in a supportive environment that values initiative and responsibility. If you're passionate about making a meaningful impact in healthcare, this role is perfect for you.

Benefits

Flexible work schedule

Remote work opportunities

Professional development

Health insurance

Collaborative work environment

Qualifications

• 2 to 5 years of experience in a Quality role within a GxP-regulated environment.
• Ability to write and implement Quality Standards and process flowcharts.

Responsibilities

• Manage QMS processes ensuring compliance with regulatory standards.
• Conduct internal and third-party audits, ensuring compliance.

Skills

Analytical thinking

Collaboration skills

Problem-solving

Communication skills

Training management

Risk management

Quality management

Education

Bachelor's in Life Sciences

PhD in Life Sciences

Tools

Microsoft Office

Electronic QMS tools

Job description

The Quality Manager is responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) in compliance with global and local GxP (good practices) regulatory requirements such as Good Clinical Practices (GCP), Good Epidemiology Practices (GEP), Good Pharmacovigilance Practices (GVP), International Organization for Standardization (ISO) as applicable. This role ensures adherence to quality standards across processes, continuous improvement, and operational excellence.

Responsibilities

The responsibilities for the Quality Manager include, but are not limited to, the following:

• Independently manage assigned QMS processes, ensuring compliance with regulatory standards;
• Write and update Written Standards (Policies, Standard Operating Procedures, Guidance, and Work Instructions);
• Lead monitoring and reporting of training compliance, identifying gaps, and ensuring corrective actions;
• Manage Quality questionnaires and due diligence activities;
• Develop and oversee the implementation and follow-up of quality and compliance metrics on deviations, corrective and preventive actions, risks and change controls, ensuring timely resolution;
• Conduct internal, site and third-party audits, ensuring compliance and identifying areas for improvement;
• Support the company in external audits and inspections, assisting in document preparation, audit/inspection hosting and follow-up actions

Experience - the ideal candidate will have

• Bachelor’s or PhD in Life Sciences;
• 2 to 5 years of experience in a Quality role within a GxP-regulated environment
• Exposure to quality questionnaires and due diligence management
• Ability to write and implement Written Standards (Policies, Standard Operating Procedures, Guidance, and Work Instructions) process flowcharts, and RACI matrixes
• Exposure to conducting internal audits, third-party audits and supporting external audits and inspections
• Good understanding of training management, risk management, deviations, corrective actions and preventive actions, and change control handling
• Strong knowledge of GCP, and electronic document, learning, and audit management systems is preferred
• Demonstrated problem-solving abilities and a continuous improvement mindset.
• Computer skills, including proficiency in Microsoft Office programs
• Good understanding of deviation, corrective and preventive action, risk and change control, and training management principles and ability to support external audits and inspections
• Familiarity with electronic QMS tools and systems
• Demonstrated critical thinking and problem-solving abilities in a Quality setting.

Experience - you must also have these skills

• Analytical thinking;
• Strong collaboration skills to engage with different departments and external partners
• Autonomous problem-solving ability, with minimal supervision required
• Proactively identifies process improvements and suggests efficiency gains
• Comfortable with training and mentoring junior team members.
• Excellent communication and interpersonal skills
• Flexibility and multitasking ability
• Thrive while working under pressure
• Work independently (and remotely) and is a great team player that solves issues in a collaborative manner
• Flexible approach to work
• Well organized and plan correctly
• Client-focused
• Focused on delivering high-quality results on time
• Sensitive to cross-cultural differences.

Why us?

You will join a young, very dynamic,and fast-growing private research organization. Our passionate, truly multicultural, and diverse team of nearly 300 colleagues and nearly 40 nationalities include epidemiologists, clinical operations, CRAs, CTAs, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and business support professionals spreading over 20 countries.

We all work remotely, setting our own time schedule, based on a “getting the job done” mentality. This has a positive impact in our work-life balance. Our headquarters are in Leuven (Belgium), but we also have local and regional offices located in Rotterdam (the Netherlands), Bogota (Colombia), Johannesburg (South Africa), Accra (Ghana), Nairobi (Kenya), Bangkok (Thailand), Paris (France), Casablanca (Morocco) and Durham (United States). You may need to travel occasionally.

At P95, we are a collaborative and international team that works on diverse projects, topics, and clients and faces interesting challenges. There is a high level of empowerment, flexibility, autonomy as well as opportunities for research and development, to make things happen. We have an open culture of respect and inclusion. Consequently, we value self-reliance, initiative, and responsibility of everyone in our team to meet our internal and external customers’ expectations. Finally, our colleagues experience a strong sense of meaning and purpose driven by the scientific nature and impact of our work.

Do you want to join us?

Visit our websitewww.p-95.com to learn more about who we are and what we do. If you are the one for this job,send your application by filling out the following short form. The call will remain open until the position is filled.
P95 is an Equal Opportunities Employer.

The company is committed to equal employment opportunities regardless of age, sexual orientation, gender, pregnancy, religion or belief, union belief, wealth, birth, nationality, ethnic origin, disability, medical history, skin color, marital status, genetic information, parental status, social origin, or condition. We base all our employment decisions on merit, job requirements and business needs.

P95, an Ampersand portfolio company, is a global provider of clinical and epidemiological services related to vaccines and infectious diseases.

Founded in 2011, we are a leader in sourcing, analyzing, and reporting epidemiological data to assist health agencies and pharmaceutical companies in improving access to safe and effective vaccines.

Headquartered in Belgium, P95 has also offices in Europe, North America, South America, South Africa, and SE Asia.

We are passionate about healthcare and helping our customers with innovative medical research. We share a sense of urgency with our customers to deliver timely, pragmatic and useful insights to improve healthcare.

Our clients are from the pharmaceutical industry, public health institutes, academic institutions, WHO, the European Commission and other governmental organizations and Non-Governmental Organizations (NGOs). Our projects focus mainly on infectious diseases, particularly on vaccines.